Medical Writing
Expect clarity, compliance, and quality. Expect more.
TFS Medical Writing at a glance
We believe that the quality of documentation can influence the flow of a clinical study. That’s why we are dedicated to providing you with the documents you need to support your drug or medical device development journey with confidence. Our medical writers provide you with documents written with clarity in the languages you require and compliant with all ICH guidelines, MDR/MDCG expectations, and relevant regulatory requirements. They are experienced in writing for key therapeutic areas and device categories for all device classes, covering all phases of clinical development and clinical evaluation, including real‑world evidence.
Cooperation, continuity, clarity
For us, experience means efficiency, and development timelines in both pharmaceuticals and medical devices are incredibly time‑sensitive. Usually, you can expect the first drafts of protocol‑related documents, CSRs, or clinical evaluation deliverables within four weeks. Further versions can be delivered within five to ten working days after receiving your comments.
Medical writing
Our expert team of writers supports you in every step of your study from beginning to end. They are skilled in writing protocols, CSRs, and clinical evaluation documents across both pharmaceutical and medical device programs, adapting to the unique regulatory and scientific requirements of each. Following is a list of the types of documents our medical writers produce for customers:
Regulatory Clinical Writing
Pharma
- Clinical development plans
- Clinical study protocols
- Clinical study reports
- Posting of clinical trial results
- Investigator brochures
- CTD clinical overview
- Investigational Medicinal Product (IMP) Dossiers
- Investigational New Drug (IND) Dossiers
- Pediatric plans
- Diversity plans
- Aggregated safety reports
- Safety signals
- Lay summaries
- Briefing documents
Medical Devices
- Clinical investigational plans
- Clinical development plans
- Clinical evaluation plans
- Clinical evaluation reports
- Literature search plans
- Literature search reports
- Vigilance search reports
- PSUR/DSUR
- Risk management plan
- PMS plan
- PMCF plan/PMCF report
Medical Communications
TFS medical writers can help you translate complex data and concepts into messages that people can understand.
Preparation of complete communication plans for product- or study programs
Abstracts, posters, and oral presentations for conferences or other meetings
Advisory board reports and scientific congress reports
Preparation of review articles, including literature reviews, systematic reviews, and meta-analyses
Scientific manuscripts of clinical trials, non-interventional studies, case reports, etc.
Educational and marketing materials (slide kits, infographics, newsletters, graphical abstracts, blogs, and web content)
Assistance with publication submission (article, abstract, poster, etc.), pre-submission scientific editing, English language review, statistical review, and revision of manuscript in response to peer review comments
Real World Evidence support
Our medical writers have a wide range of experience in:
Epidemiological studies
Post-authorization safety studies (PASS)
Post-authorization effectiveness studies (PAES)
Health outcomes research studies
Health economic studies
Choose TFS Medical Writing to support the success of your study
We take pride in our documents being accepted by our clients for submission-ready issues or health authority validation issues.
- 30 committed global medical writers with strategic long-term stability
- >90% approval of study protocols/clinical investigational plans by ethics committees and health authorities
- >95% acceptance rate of abstracts, posters, and oral communications
- 95% of manuscripts published in peer-reviewed journals
- >100 congress presentations delivered per year
- >1500 documents completed in the past five years in >15 therapeutic areas
